Q1 '21 EARNINGS CALL APRIL 27, 2021 - Amgen
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Q1 ’21 EARNINGS CALL APRIL 27, 2021
SAFE HARBOR STATEMENT
This presentation contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially
from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company, (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of
non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical
results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes
progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more
fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Please
refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of April 27, 2021 and expressly
disclaims any duty to update information contained in this presentation.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally,
clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed
care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and
other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are
on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our
commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and
product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product
development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.
In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing
product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers
have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the
affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we
have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a
number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or
repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
The information relating to our Q1 results is expressly limited to information through March 31, 2021, and future results are subject to the effects of the ongoing COVID-19 pandemic on our business, including disruptions and effects on our
product sales, and extrapolation on such results should include the timing and effects of the COVID-19 pandemic discussed in our oral presentation and our Form 10-Q for the period ended March 31, 2021.
This presentation includes GAAP and non-GAAP financial measures. In accordance with the requirements of SEC Regulation G, reconciliations between these two measures, if these slides are in hard copy, accompany the hard copy
presentation or, if these slides are delivered electronically, are available on the Company's website at www.amgen.com within the Investors section.
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 2
materially; Amgen disclaims any duty to update.AGENDA Introduction Arvind Sood Opening Remarks Bob Bradway Q1 ’21 Business Results and Outlook Peter Griffith Global Commercial Update Murdo Gordon R&D Update David Reese Q&A All Provided April 27, 2021, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 3 materially; Amgen disclaims any duty to update.
INVESTING FOR LONG-TERM GROWTH • Continued to drive volume growth and maintain leading competitive shares through the pandemic • Advanced our innovative, first-in-class pipeline with three late-stage assets having earned Breakthrough Therapy Designations from the FDA • Generated strong free cash flows and executed on our capital allocation priorities, including pipeline acquisitions • Focused on delivering long-term growth for shareholders Provided April 27, 2021, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 4 materially; Amgen disclaims any duty to update.
Q1 ’21 BUSINESS RESULTS AND OUTLOOK
Q1 2021 FINANCIAL RESULTS
$ Millions, Except Non-GAAP EPS
Item Q1 ’21 Q1 ’20 B/(W) %
Revenue $5,901 $6,161 (4%)
Product Sales 5,592 5,894 (5%)
Other Revenues 309 267 16%
Non-GAAP Operating Expenses 3,037 2,985 (2%)
Cost of Sales % of product sales 867 15.5% 771 13.1% (12%)
R&D % of product sales 944 16.9% 927 15.7% (2%)
SG&A % of product sales 1,226 21.9% 1,287 21.8% 5%
Non-GAAP Operating Income % of product sales 2,864 51.2% 3,176 53.9% (10%)
Other Income/(Expense) (375) (296) (27%)
Non-GAAP Net Income $2,150 $2,506 (14%)
Non-GAAP EPS $3.70 $4.22 (12%)
Average Shares (millions) 581 594 2%
Non-GAAP Tax Rate 13.6% 13.0% (0.6) pts.
All income statement items for Q1 ’21 and/or Q1 ’20, except revenue and average shares, are non-GAAP financial measures—if this slide is in hard copy, see reconciliations
accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section.
Provided April 27, 2021, as part of an oral presentation and is qualified by For comparability of results to the prior year, Non-GAAP Net Income and Non-
such, contains forward-looking statements, actual results may vary 6 GAAP EPS amounts for 2020 have been revised to reflect the
materially; Amgen disclaims any duty to update. update to our non-GAAP policy that excludes gains and losses on certain
equity investments.STRONG BALANCE SHEET WITH FREE CASH FLOW OF $1.9B IN Q1 2021 $ Billions, Except Dividends Paid Per Share Cash Flow Data Q1 ’21 Q1 ’20 Capital Expenditures $0.2 $0.1 Free Cash Flow* 1.9 2.0 Share Repurchases 0.9 0.9 Dividends Paid 1.0 0.9 Dividends Paid Per Share $1.76 $1.60 Balance Sheet Data 3/31/21 12/31/20 Cash and Investments $10.6 $10.6 Debt Outstanding 32.7 33.0 *Non-GAAP financial measure—if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section Provided April 27, 2021, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 7 materially; Amgen disclaims any duty to update.
2021 GUIDANCE (TAX RATE UPDATED)
Current Guidance Previous Guidance
Revenue $25.8B–$26.6B $25.8B–$26.6B
Non-GAAP EPS* $16.00–$17.00 $16.00—$17.00
Non-GAAP Tax Rate* 13.5%–14.5% 13.0%—14.0%
Capital Expenditures ~ $900M ~ $900M
*Non-GAAP financial measure—if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, or amounts
pertain to previously issued financial guidance, see reconciliations available at: www.amgen.com within the Investors section
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 8
materially; Amgen disclaims any duty to update.2020 FINANCIAL RESULTS REFLECTING NON-GAAP POLICY
UPDATE EFFECTIVE JANUARY 2021
$ Millions, Except Non-GAAP EPS
Item Q1 ’20 Q2 ’20 Q3 ’20 Q4 ’20 FY ’20
Net Income (as reported) $2,476 $2,518 $2,572 $2,229 $9,795
Equity Securities Losses/(Gains) 39 (44) (134) (265) (404)
Tax Impact (9) 10 29 58 88
Net Income (adjusted) $2,506 $2,484 $2,467 $2,022 $9,479
Diluted Shares 594 592 589 585 590
Diluted EPS (as reported) $4.17 $4.25 $4.37 $3.81 $16.60
Diluted EPS (adjusted) $4.22 $4.20 $4.19 $3.46 $16.07
Note: Effective January 2021, we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that
are recorded to other income (expense) pursuant to an update to our non-GAAP policy. This change does not apply to our strategic investment in
BeiGene, which is included in our non-GAAP results, and is accounted for under the equity method of accounting. Please note that this updated
non-GAAP policy is now the basis for our comparisons in 2021 and is reflected in our 2021 guidance.
All income statement items presented, except average shares, are non-GAAP financial measures—if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is
delivered electronically, see reconciliations available at: www.amgen.com within the Investors section
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 9
materially; Amgen disclaims any duty to update.GLOBAL COMMERCIAL UPDATE
Q1 ’21 GLOBAL COMMERCIAL UPDATE
Q1 ’21 Q1 ’20 YoY
$ Millions, Net Sales U.S. ROW Total Total Total
Prolia® $501 $257 $758 $654 16%
EVENITY® 57 50 107 100 7%
Repatha® 139 147 286 229 25%
Aimovig® 66 — 66 71 (7%)
Otezla® 366 110 476 479 (1%)
Enbrel® 894 30 924 1,153 (20%)
AMGEVITA™ — 106 106 86 23%
KYPROLIS® 159 92 251 280 (10%)
XGEVA® 334 134 468 481 (3%)
Vectibix® 79 112 191 202 (5%)
Nplate® 112 115 227 218 4%
BLINCYTO® 65 42 107 94 14%
MVASI® 224 70 294 115 156%
KANJINTI® 130 31 161 119 35%
Neulasta® 421 61 482 609 (21%)
NEUPOGEN® 18 16 34 65 (48%)
EPOGEN® 125 — 125 155 (19%)
Aranesp® 125 230 355 422 (16%)
Parsabiv® 46 33 79 175 (55%)
Sensipar®/Mimpara™ — 23 23 123 (81%)
Other* 42 30 72 64 13%
Total Product Sales $3,903 $1,689 $5,592 $5,894 (5%)
Total Revenue $5,901 $6,161 (4%)
*Other includes GENSENTA, IMLYGIC®, Corlanor®, Bergamo and AVSOLA®
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 11
materially; Amgen disclaims any duty to update.Q1 ’21 DEPICTS A PATTERN OF LOWER PRODUCT SALES AS A
PERCENTAGE OF THE FULL YEAR
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • Cumulative missed patient visits and
Total Change (5%) (12%)
ROW Units 4% (3%)
diagnoses due to the pandemic continue
U.S. Inventory 0% (5%) to impact our business
• A number of products delivered volume
growth despite continued COVID-19
effects
• YoY growth was negatively impacted by
2% due to ~ $150M of favorable changes
to estimated sales deductions in Q1 2020
Note: Inventory represents wholesaler and, based on prescription data for Otezla® and Enbrel®, end-user inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 12
materially; Amgen disclaims any duty to update.WE ARE CONFIDENT IN PROLIA®'S CONTINUED
GROWTH POTENTIAL
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY sales growth of 16% driven by volume
Total Change 16% 1%
ROW Units 13% 2% growth
U.S. Inventory (1%) (5%)
• New and repeat patient volumes continue
to recover from pandemic
• Osteoporosis diagnosis rates in the U.S.
returned to ~ 90% of pre-COVID-19 levels
• Confident in continued growth in 2021
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 13
materially; Amgen disclaims any duty to update.EVENITY® GROWTH DRIVEN BY STRONG DEMAND
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • U.S. sales increased 54% YoY, driven by
Total Change 7% 19%
ROW Units 9% 27% 67% volume growth
U.S. Inventory (2%) (3%)
• ROW sales decreased 21% YoY, partially
driven by timing of purchases by Astellas,
our partner in Japan, in H1 2020
Note: Inventory represents wholesaler inventories
EVENITY® is developed and commercialized in collaboration with UCB globally, as well as our collaboration partner Astellas in Japan
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 14
materially; Amgen disclaims any duty to update.REPATHA® DEMAND CONTINUES TO GROW
GLOBALLY
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY increase driven by volume growth,
Total Change 25% 13%
ROW Units 36% 12% partially offset by lower net selling price*
U.S. Inventory (1%) (2%) and the effect of favorable changes to
estimated sales deductions in Q1 2020
• ROW volume growth of 42%
• Given the increase in U.S. Medicare Part
D patients receiving Repatha®, we expect
some additional reduction in net price
on a sequential basis
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 15
materially; Amgen disclaims any duty to update.AIMOVIG® REMAINS THE LEADER WITHIN THE
PREVENTIVE CGRP CLASS
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY decrease despite volume growth of
Total Change (7%) (37%)
Units 20% (1%) 20%; driven by lower net selling price* and
U.S. Inventory 3% (3%) unfavorable changes to estimated sales
deductions
• CGRP segment leader with 45% average
share of total prescriptions and 38% average
share of new-to-brand prescriptions in the
quarter
• Recent head-to-head data vs. topiramate
demonstrate superior efficacy and
tolerability
CGRP = calcitonin gene-related peptide; *Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories; Aimovig® is commercialized in collaboration with Novartis
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 16
materially; Amgen disclaims any duty to update.WE SEE ATTRACTIVE GROWTH OPPORTUNITIES FOR
OTEZLA® AS THE PANDEMIC RECOVERY CONTINUES
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • Slight YoY decrease driven by declines
Total Change (1%) (23%)
ROW Units 9% 1% in net selling price* and inventory,
U.S. Inventory (4%) (13%) substantially offset by volume growth
• Total prescriptions grew 11% in the U.S.
• New-to-brand prescription volumes
remained flat as COVID-19 continues to
suppress diagnosis and treatment of
psoriasis patients
• Continued geographic expansion and
new indications provide opportunities
for growth
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler and, based on prescription data, end-user inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 17
materially; Amgen disclaims any duty to update.ENBREL® HAS A LONG ESTABLISHED RECORD OF
SAFETY AND EFFICACY
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY sales declined in Q1 driven by
Total Change (20%) (27%) unfavorable changes to estimated sales
ROW Units (6%) (7%)
U.S. Inventory 1% (7%)
deductions, volume declines and lower net
selling price*
33
36 36 • Of the ~ $255M in favorable changes to
36
estimated sales deductions realized in
30
2020, ~ $115M of these changes occurred
in Q1 2020 and did not repeat this quarter
• Going forward, we expect volume and net
selling price* trends to continue
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler and, based on prescription data, end-user inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 18
materially; Amgen disclaims any duty to update.AMGEVITA™ REMAINS THE MOST PRESCRIBED
ADALIMUMAB BIOSIMILAR IN EUROPE
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ
Total Change 23% 3%
• YoY increase driven by volume growth
ROW Units 34% 4% as we expand geographically outside
Inventory 0% 0% the U.S., partially offset by lower net
selling price*
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 19
materially; Amgen disclaims any duty to update.KYPROLIS® COMBINATION REGIMENS EXPECTED
TO DELIVER FUTURE GROWTH
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY decrease primarily as a result of
Total Change (10%) (8%)
ROW Units (6%) (7%) slower growth in multiple myeloma
U.S. Inventory (2%) (1%) segment as fewer patients were
diagnosed and treated due to COVID-19
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 20
materially; Amgen disclaims any duty to update.STRONG XGEVA® VOLUME GROWTH IN ASIA
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY decrease driven by lower net
Total Change (3%) (7%)
ROW Units 6% 0% selling price* in Asia, partially offset by
U.S. Inventory (1%) (4%) volume growth in that region
• U.S. unit volumes declined YoY driven
by demand impacts from COVID-19 in
January and February, with recovery
beginning in March and into April
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 21
materially; Amgen disclaims any duty to update.VECTIBIX® SALES DECLINED 5% YOY
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY decrease driven by timing of
Total Change (5%) (14%)
ROW Units (5%) (10%) shipments to Takeda, our partner in
U.S. Inventory (1%) (4%) Japan, in Q1 2020
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 22
materially; Amgen disclaims any duty to update.NPLATE® SALES GREW 4% YOY
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY increase driven by 23% volume
Total Change 4% 0%
ROW Units 6% 6% growth in ROW regions, partially offset
U.S. Inventory (2%) (7%) by declines in U.S. sales
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 23
materially; Amgen disclaims any duty to update.BLINCYTO® SALES GREW 14% YOY
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY increase driven by volume growth
Total Change 14% 4%
ROW Units 15% 4% due to the broader adoption in the
U.S. Inventory (3%) (2%) community hospital setting
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 24
materially; Amgen disclaims any duty to update.MVASI® IS THE MARKET LEADER OF THE
BEVACIZUMAB SEGMENT IN THE U.S.
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ
Total Change 156% 5%
• YoY increase driven by strong volume
ROW Units 193% 8% growth and favorable changes to
U.S. Inventory (1%) (3%) estimated sales deductions, partially
offset by lower net selling price*
• Expect MVASI® launches across multiple
markets in 2021 to drive worldwide
volume growth, offset by declines in net
7 selling price* due to increased
competition
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 25
materially; Amgen disclaims any duty to update.KANJINTI® IS THE MARKET LEADER OF THE
TRASTUZUMAB SEGMENT IN THE U.S.
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY increase driven by volume growth,
Total Change 35% 2%
ROW Units 83% 3% partially offset by lower net selling price*
U.S. Inventory 0% (3%)
• 2% sales growth QoQ as favorable
changes to estimated sales deductions
were offset by price declines
• Expect net selling price to continue to
decline going forward due to increased
competition
*Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 26
materially; Amgen disclaims any duty to update.NEULASTA® ONPRO® REACHES NEW MILESTONE
WITH OVER ONE MILLION PATIENTS TREATED
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY decrease driven by declines in net
Total Change (21%) (10%)
ROW Units (8%) (7%) selling price* and unit volumes, partially
U.S. Inventory 2% (2%) offset by favorable changes to estimated
sales deductions
• Onpro® continues to be preferred by
patients and physicians, and maintained
54% share
• The most recent published ASP for U.S.
Neulasta® declined 30% YoY and 9% QoQ
ASP = average selling price; *Net selling price represents the impact of list price changes as well as contracting and access changes
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 27
materially; Amgen disclaims any duty to update.PARSABIV® SALES IMPACTED DUE TO INCLUSION IN
BUNDLED PAYMENT SYSTEM IN THE U.S.
$ Millions, Net Sales Q1 ’21 Highlights
Q1 ’21 YoY QoQ • YoY decrease driven by volume declines
Total Change (55%) (54%)
ROW Units (65%) (63%) • Expect declining YoY sales trend to
U.S. Inventory 5% (1%) continue through 2021
• Parsabiv® remains the only IV-
administered calcimimetic that treats
secondary hyperparathyroidism
Note: Inventory represents wholesaler inventories
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 28
materially; Amgen disclaims any duty to update.R&D UPDATE
Q1 ’21 EARNINGS CALL—R&D UPDATE
LUMAKRAS™ (sotorasib)
• Eight global regulatory submissions for advanced NSCLC
– Priority Review in U.S.—August 16, 2021 FDA PDUFA target action date
• Broadest global KRASG12C program
– > 800 patients with 13 tumor types enrolled across five continents
– Phase 3 NSCLC study enrollment completed
– Phase 2 mCRC data expected H1—submissions for data publication/presentation planned for H2
– Phase 2 “other solid tumors” study enrollment completed—data expected H1 2022
– Phase 2 sub-study evaluating 240 mg QD vs. 960 mg QD in NSCLC patients initiated—no impact
expected on FDA Priority Review timelines
– > 10 Phase 1b combination cohorts underway—submissions of initial data from the MEK, oral
EGFR and EGFR Ab combinations are planned for presentation in H2 2021
• Differentiated safety profile—no treatment-related fatalities, most AEs mild to moderate
PDUFA = Prescription Drug user Fee Act; KRAS G12C = Kirsten rat sarcoma viral oncogene homolog with G12C mutation; NSCLC = non-small cell lung cancer; mCRC = metastatic colorectal cancer; MEK = mitogen-activated
protein kinase kinase; EGFR = epidermal growth factor receptor; Ab = antibody; AE = adverse event; The trade name LUMAKRAS™ is provisionally approved for use by the U.S. FDA
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 30
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
LUMAKRAS™ (continued)
ClinicalTrials.gov Advanced KRAS G12C-Mutated Cancers Phase
Clinical Trial NCT ID Treatments NSCLC CRC Other Solid Tumors
NCT04303780 Monotherapy vs. docetaxel 3
Monotherapy 2
NCT03600883 Monotherapy (Treatment Naïve) 1
+ PD-1/PD-L1 inhibitor 1
+ Oral EGFR inhibitor 1b
+ PD-L1 inhibitor 1b
+ Chemotherapy 1b
+ EGFR Ab +/- Chemotherapy 1b
NCT04185883 + VEGF Ab + Chemotherapy 1b
+ PD-1 inhibitor 1b
+ MEK inhibitor +/- EGFR Ab 1b
+ SHP2 inhibitor 1b
+ mTOR inhibitor 1b
+ CDK inhibitor 1b
NCT04380753 Monotherapy* 1
NCT = National Clinical Trial number; NSCLC = non-small cell lung cancer; CRC = colorectal cancer; PD-1 = programmed cell death protein 1; PD-L1 = programmed death-ligand 1; TKI = tyrosine kinase inhibitor; EGFR Ab = epidermal growth factor receptor antibody; VEGF = vascular endothelial growth factor;
MEK = mitogen-activated protein kinase kinase; SHP2 = Src homology region 2-containing protein tyrosine phosphatase 2; mTOR = mammalian target of rapamycin; CDK = cyclin-dependent kinase; *In subjects of Chinese descent; The trade name LUMAKRASTM is provisionally approved for use by the U.S. FDA
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 31
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Oncology/Hematology
• Bemarituzumab—anti-FGFR2b Ab
– Phase 3 planning underway for the treatment of patients with HER2-negative, FGFR2b-
positive gastric and gastroesophageal junction cancer
– Breakthrough Therapy Designation as first-line treatment for patients with FGFR2b-
overexpressing and HER2-negative metastatic and locally advanced gastric and
gastroesophageal adenocarcinoma in combination with modified FOLFOX6
(fluoropyrimidine, leucovorin and oxaliplatin), based on an FDA-approved companion
diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b
– Planning to investigate bemarituzumab in other solid tumors, including squamous cell
NSCLC
FGFR2b = fibroblast growth factor receptor 2b; HER2 = human epidermal growth factor receptor 2
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 32
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Oncology/Hematology (continued)
• Acapatamab (AMG 160)—HLE BiTE® molecule targeting PSMA
– A dose expansion cohort continues to enroll patients with mCRPC. Enrollment is ongoing in cohorts with reduced
levels of monitoring during cycle one to explore outpatient administration
– A dose escalation study has initiated for PSMA-positive NSCLC
– A master protocol evaluating combinations of acapatamab with AMG 404 (anti-PD-1 antibody), enzalutamide or
abiraterone, is enrolling patients with earlier-line mCRPC
• AMG 757—HLE BiTE® molecule targeting DLL3
– Completed dose escalation in patients with relapsed or refractory SCLC and expect to initiate the expansion phase
by H2 of this year
– A Phase 1b study of AMG 757 has initiated for patients with neuroendocrine prostate cancer
– A Phase 1b study of AMG 757 in combination with AMG 404 is planned to initiate in Q3 2021 for patients with small
cell lung cancer
• Pavurutamab (AMG 701)—HLE BiTE® molecule targeting BCMA
– Enrollment is anticipated to resume in May in the dose escalation study of pavurutamab for patients with relapsed or
refractory multiple myeloma
HLE = half-life extended; BiTE® = bispecific T-cell engager; PSMA = prostate-specific membrane antigen; mCRPC = metastatic castrate resistant prostate cancer; DLL3 = delta-like ligand 3;
SCLC = small cell lung cancer; BCMA = B-cell maturation antigen
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 33
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Oncology/Hematology (continued)
• The following programs continue to enroll patients in dose escalation studies
– AMG 330, a BiTE® molecule targeting CD33, and AMG 427, an HLE BiTE molecule targeting
FLT3, for acute myeloid leukemia
– AMG 176, a small molecule inhibitor of MCL-1 for hematologic malignancies
– HLE BiTE® molecules AMG 199 targeting MUC17 and AMG 910 targeting CLDN18.2 for
gastric and gastroesophageal junction cancer
– AMG 509, a bivalent T-cell engager XmAb® 2+1 antibody targeting STEAP1 for prostate
cancer
– AMG 256, a bifunctional interleukin-21 agonist for PD-1-positive solid tumors
FLT3 = fms-like tyrosine kinase 3; MCL-1 = myeloid cell leukemia-1; MUC17 = mucin-17; CLDN18.2 = claudin 18.2; STEAP1 = six transmembrane epithelial antigen of the prostate 1
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 34
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Inflammation
• Tezepelumab—TSLP monoclonal Ab
– Results from the pivotal Phase 3 NAVIGATOR study demonstrating significant
reductions in exacerbations in a broad population of patients with severe uncontrolled
asthma were presented at the AAAAI Virtual Annual Meeting in February. Additional
NAVIGATOR data will be presented at the ATS International Conference in May
– Regulatory submissions in the U.S. and EU are expected in Q2 2021
– A Phase 2 study continues to enroll patients with COPD
– A Phase 2b study is enrolling patients with chronic spontaneous urticaria
– A Phase 3 study for patients with chronic rhinosinusitis with nasal polyps has initiated
TSLP = thymic stromal lymphopoietin; AAAAI = American Academy of Allergy, Asthma and Immunology; ATS = American Thoracic Society; COPD = chronic obstructive pulmonary disease
Tezepelumab is being developed in collaboration with AstraZeneca
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 35
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Inflammation (continued)
• Otezla®
– In April, an sNDA for the treatment of adults with mild-to-moderate plaque psoriasis
was submitted to the FDA based on the results of the Phase 3 ADVANCE study, which
were presented at the AAD Virtual Experience in April
– A Phase 2 study in Japanese patients with palmoplantar pustulosis successfully
completed and data will be submitted to an upcoming medical conference. Planning for
a Phase 3 study in Japan is underway
– The Otezla® arm of the Phase 2, open-label I-SPY COVID adaptive platform trial being
conducted in critically ill COVID-19 patients was stopped for futility upon
recommendation from the Data Monitoring Committee
– COMMUNITY, an adaptive placebo-controlled, double-blind, Phase 3 platform study
evaluating adult patients hospitalized with COVID-19, is ongoing
sNDA = supplemental New Drug Application; AAD = American Academy of Dermatology
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 36
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Inflammation (continued)
• Efavaleukin alfa (AMG 592)—IL-2 mutein
– A Phase 2b study has been initiated, and enrollment of patients with SLE is expected to
begin in Q2 2021
– Data from the Phase 1b SLE study will be submitted to a medical conference in H2 2021
• Rozibafusp alfa (AMG 570)—Ab-peptide conjugate that blocks ICOSL and
BAFF activity
– A Phase 2b study continues to enroll patients with SLE
• AMG 714 / PRV-015—IL-15 monoclonal Ab
– A Phase 2b study continues to enroll patients with non-responsive celiac disease
IL-2 = interleukin 2;SLE = systemic lupus erythematosus; ICOSL = inducible T-cell costimulatory ligand; BAFF = B-cell activating factor; IL-15 = interleukin 15
AMG 714 (also known as PRV-015) is being developed in collaboration with Provention Bio
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 37
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL—R&D UPDATE
Cardiovascular
• Repatha®
– In February, a variation to the marketing application was submitted to the European Medicines
Agency for a new indication for pediatric patients with HeFH and to include additional results in the
label for pediatric patients with HoFH
• Olpasiran (AMG 890)—Lipoprotein (a) siRNA
– Enrollment completed in a Phase 2 study in patients with elevated lipoprotein(a)—data expected H1
2022
Biosimilars
• Phase 3 studies of ABP 654, a biosimilar candidate to STELARA® (ustekinumab), and ABP
938, a biosimilar candidate to EYLEA® (aflibercept), continue to enroll patients
• A Phase 3 study of ABP 959, a biosimilar candidate to SOLIRIS® (eculizumab), is ongoing
HeFH = heterozygous familial hypercholesterolemia; HoFH = homozygous familial hypercholesterolemia; siRNA = small interfering ribonucleic acid; STELARA® is a registered trademark of
Janssen Pharmaceutica NV; EYLEA® is a registered trademark of Regeneron Pharmaceuticals, Inc.; SOLIRIS® is a registered trademark of Alexion Pharmaceuticals, Inc.
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 38
materially; Amgen disclaims any duty to update.Additional ongoing clinical programs can be found at
Amgenpipeline.comQ1 ’21 EARNINGS CALL APRIL 27, 2021
RECONCILIATIONS
Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per - share data)
(Unaudited) Three months ended
March 31,
2021 2020
Revenues:
Product sales $5,592 $5,894
Other revenues 309 267
Total revenues 5,901 6,161
Operating expenses:
Cost of sales 1,490 1,513
Research and development 967 952
Selling, general and administrative 1,254 1,316
Other 61 25
Total operating expenses 3,772 3,806
Operating income 2,129 2,355
Other income (expense):
Interest expense, net (285) (346)
Other income, net 13 11
Income before income taxes 1,857 2,020
Provision for income taxes 211 195
Net income $1,646 $1,825
Earnings per share:
Basic $2.85 $3.09
Diluted $2.83 $3.07
Shares used in calculation of earnings per share:
Basic 577 590
Diluted 581 594
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 42
materially; Amgen disclaims any duty to update.Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions) March 31, December 31,
2021 2020
(Unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable securities $10,566 $10,647
Trade receivables, net 4,423 4,525
Inventories 4,017 3,893
Other current assets 2,293 2,079
Total current assets 21,299 21,144
Property, plant and equipment, net 4,855 4,889
Intangible assets, net 15,947 16,587
Goodwill 14,673 14,689
Other assets 5,765 5,639
Total assets $62,539 $62,948
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $11,313 $11,562
Current portion of long-term debt 1,556 91
Total current liabilities 12,869 11,653
Long-term debt 31,129 32,895
Long-term tax liabilities 7,037 6,968
Other noncurrent liabilities 2,170 2,023
Total stockholders’ equity 9,334 9,409
Total liabilities and stockholders’ equity $62,539 $62,948
Shares outstanding 575 578
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 43
materially; Amgen disclaims any duty to update.Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars In millions)
(Unaudited)
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 44
materially; Amgen disclaims any duty to update.Amgen Inc.
GAAP to Non-GAAP Reconciliations
(In millions, except per-share data)
(Unaudited)
(Continued from previous slide)
The following table presents the computations for GAAP and non-GAAP diluted earnings per share:
Three months ended Three months ended
March 31, 2021 March 31, 2020*
GAAP Non-GAAP GAAP Non-GAAP
Net income $1,646 $2,150 $1,825 $2,506
Weighted-average shares for diluted EPS 581 581 594 594
Diluted EPS $2.83 $3.70 $3.07 $4.22
*Effective January 2021, we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to Other income, net pursuant to
an update to our non-GAAP policy. For comparability of results to the prior year, non-GAAP Other income, net, non-GAAP net income and non-GAAP EPS amounts for 2020 have been
revised to reflect the update to our non-GAAP policy.
a. The adjustments related primarily to noncash amortization of intangible assets from business acquisitions.
b. For the three months ended March 31, 2020, the adjustments related primarily to an impairment charge associated with a nonkey in-process research and development asset.
c. The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax
jurisdiction(s). Generally, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including the majority of amortization of intangible assets, whereas the tax impact of other
adjustments, including restructuring and other cost savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those
jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes, for the three months ended March 31, 2021, was 20.7%, compared to 20.9%
for the corresponding period of the prior year.
d. The adjustments related to certain acquisition items and prior period items excluded from GAAP earnings.
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 45
materially; Amgen disclaims any duty to update.Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)
Three months ended
March 31,
2021 2020
Net cash provided by operating activities $ 2,104 $ 2,134
Net cash used in investing activities (319) (230)
Net cash used in financing activities (1,939) (254)
(Decrease) increase in cash and cash equivalents (154) 1,650
Cash and cash equivalents at beginning of period 6,266 6,037
Cash and cash equivalents at end of period $ 6,112 $ 7,687
Three months ended
March 31,
2021 2020
Net cash provided by operating activities $ 2,104 $ 2,134
Capital expenditures (166) (142)
Free cash flow $ 1,938 $ 1,992
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 46
materially; Amgen disclaims any duty to update.Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2021
(Unaudited)
GAAP diluted EPS guidance $9.11 — $10.71
Known adjustments to arrive at non-GAAP*:
Acquisition-related expenses (a) 3.90 — 3.98
Acquired IPR&D (b) 2.50 — 3.02
Certain charges pursuant to our cost savings initiatives 0.07
Net (gains)/losses from equity investments (0.20)
Legal proceedings 0.02
Non-GAAP diluted EPS guidance $16.00 — $17.00
* The known adjustments are presented net of their related tax impact, which amount to approximately $0.98 per share.
(a) The adjustments relate primarily to noncash amortization of intangible assets acquired in business acquisitions.
(b) The adjustment relates to in-process research & development (IPR&D) expense as a result of acquiring Five Prime Therapeutics in April 2021. The acquired IPR&D is
not tax deductible.
Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as
acquisitions, asset impairments, litigation, changes in the fair value of our contingent consideration and changes in fair value of our equity investments.
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2021
(Unaudited)
GAAP tax rate guidance 14.0 % — 15.5 %
Tax rate of known adjustments discussed above (1.0%) — (0.5%)
Non-GAAP tax rate guidance 13.5 % — 14.5 %
Provided April 27, 2021, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary 47
materially; Amgen disclaims any duty to update.Q1 ’21 EARNINGS CALL APRIL 27, 2021
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